Oseltamivir Phosphate for Oral Suspension

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Overview

What is Oseltamivir Phosphate for Oral Suspension?

Oseltamivir phosphate is available as a powder for oral suspension, which when constituted with water as directed contains 6 mg/mL oseltamivir base. In addition to the active ingredient, the powder for oral suspension contains sorbitol, monosodium citrate, titanium dioxide, tutti-frutti flavoring, colloidal silicon dioxide, sodium benzoate, xanthan gum, and saccharin sodium.

Oseltamivir phosphate is a white to off-white powder with the chemical name (3R,4R,5S)-4-acetylamino-5-amino3(1-ethylpropoxy)-1-cyclohexene-1-carboxylic acid, ethyl ester, phosphate (1:1). The chemical formula is CHNO (free base). The molecular weight is 312.4 for oseltamivir free base and 410.4 for oseltamivir phosphate salt. The structural formula is as follows:

What does Oseltamivir Phosphate for Oral Suspension look like?

What are the available doses of Oseltamivir Phosphate for Oral Suspension?

What should I talk to my health care provider before I take Oseltamivir Phosphate for Oral Suspension?

How should I use Oseltamivir Phosphate for Oral Suspension?

What interacts with Oseltamivir Phosphate for Oral Suspension?

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What are the warnings of Oseltamivir Phosphate for Oral Suspension?

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What are the precautions of Oseltamivir Phosphate for Oral Suspension?

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What are the side effects of Oseltamivir Phosphate for Oral Suspension?

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What should I look out for while using Oseltamivir Phosphate for Oral Suspension?

Oseltamivir Phosphate for Oral Suspension is contraindicated in patients with known serious hypersensitivity to oseltamivir or any component of the product. Severe allergic reactions have included anaphylaxis and serious skin reactions including toxic epidermal necrolysis, Stevens-Johnson Syndrome, and erythema multiforme.

What might happen if I take too much Oseltamivir Phosphate for Oral Suspension?

Reports of overdoses with Oseltamivir Phosphate for Oral Suspension have been received from clinical trials and during postmarketing experience. In the majority of cases reporting overdose, no adverse reactions were reported. Adverse reactions reported following overdose were similar in nature to those observed with therapeutic doses of Oseltamivir Phosphate for Oral Suspension.

How should I store and handle Oseltamivir Phosphate for Oral Suspension?

Oseltamivir Phosphate for Oral SuspensionSupplied as a white to off-white granular powder in a glass bottle. After constitution, the powder blend produces a white to off-white tutti-frutti–flavored oral suspension. After constitution with 55 mL of water, each bottle delivers a usable volume of 60 mL of oral suspension equivalent to 360 mg oseltamivir base (6 mg/mL). (NDC 47781-384-26)StorageStore dry powder at 25ºC (77ºF); excursions permitted to 15º to 30ºC (59º to 86ºF) [See USP Controlled Room Temperature].Store constituted suspension under refrigeration for up to 17 days at 2º to 8ºC (36º to 46ºF). Do not freeze. Alternatively, store constituted suspension for up to 10 days at 25ºC (77ºF); excursions permitted to 15º to 30ºC (59º to 86ºF) [See USP Controlled Room Temperature]. Oseltamivir Phosphate for Oral SuspensionSupplied as a white to off-white granular powder in a glass bottle. After constitution, the powder blend produces a white to off-white tutti-frutti–flavored oral suspension. After constitution with 55 mL of water, each bottle delivers a usable volume of 60 mL of oral suspension equivalent to 360 mg oseltamivir base (6 mg/mL). (NDC 47781-384-26)StorageStore dry powder at 25ºC (77ºF); excursions permitted to 15º to 30ºC (59º to 86ºF) [See USP Controlled Room Temperature].Store constituted suspension under refrigeration for up to 17 days at 2º to 8ºC (36º to 46ºF). Do not freeze. Alternatively, store constituted suspension for up to 10 days at 25ºC (77ºF); excursions permitted to 15º to 30ºC (59º to 86ºF) [See USP Controlled Room Temperature]. Oseltamivir Phosphate for Oral SuspensionSupplied as a white to off-white granular powder in a glass bottle. After constitution, the powder blend produces a white to off-white tutti-frutti–flavored oral suspension. After constitution with 55 mL of water, each bottle delivers a usable volume of 60 mL of oral suspension equivalent to 360 mg oseltamivir base (6 mg/mL). (NDC 47781-384-26)StorageStore dry powder at 25ºC (77ºF); excursions permitted to 15º to 30ºC (59º to 86ºF) [See USP Controlled Room Temperature].Store constituted suspension under refrigeration for up to 17 days at 2º to 8ºC (36º to 46ºF). Do not freeze. Alternatively, store constituted suspension for up to 10 days at 25ºC (77ºF); excursions permitted to 15º to 30ºC (59º to 86ºF) [See USP Controlled Room Temperature]. Oseltamivir Phosphate for Oral SuspensionSupplied as a white to off-white granular powder in a glass bottle. After constitution, the powder blend produces a white to off-white tutti-frutti–flavored oral suspension. After constitution with 55 mL of water, each bottle delivers a usable volume of 60 mL of oral suspension equivalent to 360 mg oseltamivir base (6 mg/mL). (NDC 47781-384-26)StorageStore dry powder at 25ºC (77ºF); excursions permitted to 15º to 30ºC (59º to 86ºF) [See USP Controlled Room Temperature].Store constituted suspension under refrigeration for up to 17 days at 2º to 8ºC (36º to 46ºF). Do not freeze. Alternatively, store constituted suspension for up to 10 days at 25ºC (77ºF); excursions permitted to 15º to 30ºC (59º to 86ºF) [See USP Controlled Room Temperature]. Oseltamivir Phosphate for Oral SuspensionSupplied as a white to off-white granular powder in a glass bottle. After constitution, the powder blend produces a white to off-white tutti-frutti–flavored oral suspension. After constitution with 55 mL of water, each bottle delivers a usable volume of 60 mL of oral suspension equivalent to 360 mg oseltamivir base (6 mg/mL). (NDC 47781-384-26)StorageStore dry powder at 25ºC (77ºF); excursions permitted to 15º to 30ºC (59º to 86ºF) [See USP Controlled Room Temperature].Store constituted suspension under refrigeration for up to 17 days at 2º to 8ºC (36º to 46ºF). Do not freeze. Alternatively, store constituted suspension for up to 10 days at 25ºC (77ºF); excursions permitted to 15º to 30ºC (59º to 86ºF) [See USP Controlled Room Temperature].

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Clinical Information

Chemical Structure

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Clinical Pharmacology

Oseltamivir is an antiviral drug with activity against influenza virus.

Non-Clinical Toxicology

Oseltamivir Phosphate for Oral Suspension is contraindicated in patients with known serious hypersensitivity to oseltamivir or any component of the product. Severe allergic reactions have included anaphylaxis and serious skin reactions including toxic epidermal necrolysis, Stevens-Johnson Syndrome, and erythema multiforme.

Due to the potential for additive effects, caution and careful titration are warranted in patients receiving diltiazem concomitantly with other agents known to affect cardiac contractility and/or conduction (see ). Pharmacologic studies indicate that there may be additive effects in prolonging AV conduction when using beta-blockers or digitalis concomitantly with diltiazem (see ).

As with all drugs, care should be exercised when treating patients with multiple medications. Diltiazem is both a substrate and an inhibitor of the cytochrome P-450 3A4 enzyme system. Other drugs that are specific substrates, inhibitors, or inducers of this enzyme system may have a significant impact on the efficacy and side effect profile of diltiazem. Patients taking other drugs that are substrates of CYP450 3A4, especially patients with renal and/or hepatic impairment, may require dosage adjustment when starting or stopping concomitantly administered diltiazem in order to maintain optimum therapeutic blood levels.

Anesthetics:

Benzodiazepines:

Beta-blockers:

Administration of diltiazem hydrochloride concomitantly with propranolol in five normal volunteers resulted in increased propranolol levels in all subjects and bioavailability of propranolol was increased approximately 50%. , propranolol appears to be displaced from its binding sites by diltiazem. If combination therapy is initiated or withdrawn in conjunction with propranolol, an adjustment in the propranolol dose may be warranted (see ).

Buspirone:

Carbamazepine:

Cimetidine:

Clonidine:

Cyclosporine:

The effect of cyclosporine on diltiazem plasma concentrations has not been evaluated.

Quinidine:

Rifampin:

Statins:

In a healthy volunteer cross-over study (N=10), coadministration of a single 20 mg dose of simvastatin at the end of a 14 day regimen with 120 mg BID diltiazem sustained-release resulted in a 5-fold increase in mean simvastatin AUC versus simvastatin alone. Subjects with increased average steady-state exposures of diltiazem showed a greater fold increase in simvastatin exposure. Computer-based simulations showed that at a daily dose of 480 mg of diltiazem, an 8- to 9-fold mean increase in simvastatin AUC can be expected. If coadministration of simvastatin with diltiazem is required, limit the daily doses of simvastatin to 10 mg and diltiazem to 240 mg.

In a ten-subject randomized, open label, 4-way cross-over study, coadministration of diltiazem (120 mg BID diltiazem sustained-release for 2 weeks) with a single 20 mg dose of lovastatin resulted in 3- to 4-fold increase in mean lovastatin AUC and C versus lovastatin alone. In the same study, there was no significant change in 20 mg single dose pravastatin AUC and C during diltiazem coadministration. Diltiazem plasma levels were not significantly affected by lovastatin or pravastatin.

The following serious adverse reactions are discussed below and elsewhere in the labeling:

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Reference

This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"

While we update our database periodically, we cannot guarantee it is always updated to the latest version.

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Professional

Clonazepam Description Each single-scored tablet, for oral administration, contains 0.5 mg, 1 mg, or 2 mg Clonazepam, USP, a benzodiazepine. Each tablet also contains corn starch, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and povidone. Clonazepam tablets USP 0.5 mg contain Yellow D&C No. 10 Aluminum Lake. Clonazepam tablets USP 1 mg contain Yellow D&C No. 10 Aluminum Lake, as well as FD&C Blue No. 1 Aluminum Lake. Chemically, Clonazepam, USP is 5-(o-chlorophenyl)-1,3-dihydro-7-nitro-2H-1,4-benzodiazepin-2-one. It is a light yellow crystalline powder. It has the following structural formula: C15H10ClN3O3 M.W. 315.72

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Interactions

A total of 440 drugs (1549 brand and generic names) are known to interact with Imbruvica (ibrutinib). 228 major drug interactions (854 brand and generic names) 210 moderate drug interactions (691 brand and generic names) 2 minor drug interactions (4 brand and generic names) Show all medications in the database that may interact with Imbruvica (ibrutinib).

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